INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES 16
Geneva, 23 March - 1 April 1981
The International Programme on Chemical Safety (IPCS),
established in 1980, is a joint venture of the United Nations
Environment Programme (UNEP), the International Labour Organisation
(ILO), and the World Health Organization (WHO). The overall objectives
of the IPCS are to establish the scientific basis for assessment of
the risk to human health and the environment from exposure to
chemicals, through international peer-review processes, as a
prerequisite for the assistance in strengthening national capacities
for the sound management of chemicals.
The Inter-Organization Programme for the Sound Management of
Chemicals (IOMC) was established in 1995 by UNEP, ILO, the Food and
Agriculture Organization of the United Nations, WHO, the United
Nations Industrial Development Organization and the Organisation for
Economic Co-operation and Development (Participating Organizations),
following recommendations made by the 1992 UN Conference on
Environment and Development to strengthen cooperation and increase
coordination of the policies and activities pursued by the
Participating Organizations, jointly or separately, to achieve the
sound management of chemicals in relation to human health and the
environment.
WHO Food Additives Series, 1981, No. 16
TOXICOLOGICAL EVALUATION OF CERTAIN FOOD ADDITIVES
The evaluations contained in this document
were prepared by the Joint FAO/WHO
Expert Committee on Food Additives*
Geneva, 23 March - 1 April 1981
INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
IPCS
* Twenty-fifth report of the Joint FAO/WHO Expert Committee on Food
Additives, Geneva, Wld Hlth Org. techn. Rep. Ser., 669, 1981.
INTRODUCTION
The monographs contained in this document have been prepared by
the Joint FAO/WHO Expert Committee on Food Additives which was held in
Geneva, 23 March - 1 April 1981.
Any new information and comments on the biological and
toxicological data should be addressed to: International Programme on
Chemical Safety (Food), Division of Environmental Health, World Health
Organization, Avenue Appia, 1211 Geneva 27, Switzerland.
JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES
Geneva, 23 March - 1 April 1981
Members invited by FAO
Professor I. S. Bhatia, Professor of Chemistry and Biochemistry,
Punjab Agricultural University, Ludhiana, India
Dr W. H. B. Denner, Principal Scientific Officer, Food Science
Division, Ministry of Agriculture, Fisheries and Food, London,
England
Dr S. W. Gunner, Acting Chief, Division of Additives and Pesticides,
Bureau of Chemical Safety, Food Directorate, Health Protection
Branch, Department of National Health and Welfare, Ottawa, Canada
Professor K. Kojima, College of Environmental Health, Azabu
University, Sagamihara, Japan
Dr W. Kroenert, Head, Food Chemistry Division, Federal Health
Institute, Berlin (West) (Vice-Chairman)
Dr P. F. Noordervliet, Manager, Product Development, Gist-Brocades NV,
Delft, Netherlands
Professor F. J. Pellerin, Faculty of Pharmacy, University of Paris XI,
Emile Roux Hospital Centre, Eaubonne, France
Members invited by WHO
Dr H. Blumenthal, Director, Division of Toxicology, Bureau of Foods,
Food and Drug Administration, Washington, D.C., United States of
America
Dr B. Briski, Divisional Chief, Laboratory for Food and Food Additives
Analysis, Department of Nutrition, Institute of Public Health of
Croatia, Zagreb, Yugoslavia
Professor F. A. Fairweather, Director, Toxicology Unit, Department of
Health and Social Security, London, England (Chairman)
Dr G. Nazario, Food Standards Commission, National Health Council,
Ministry of Health, Rio de Janeiro, Brazil
Professor I. Nir, Department of Pharmacology, Hebrew University
Hadassah Medical School, Jerusalem, Israel
Professor M. J. Rand, Chairman, Department of Pharmacology, University
of Melbourne, Victoria, Australia (Rapporteur)
Observer invited by FAO
Mr A. Feberwee, Chairman, Codex Committee on Food Additives, c/o
Ministry of Agriculture and Fisheries, The Hague, Netherlands
Secretariat
Dr J. R. P. Cabral, Division of Chemical and Biological
Carcinogenesis, International Agency for Research on Cancer,
Lyons, France
Dr P.S. Elias, Director, International Food Irradiation Programme,
Federal Research Centre for Nutrition, Karlsruhe, Federal
Republic of Germany (WHO Temporary Adviser)
Professor R. Ferrando, National Veterinary School, Alfort, France
(FAO Temporary Adviser)
Dr C. L. Galli, Department of Pharmacology and Pharmacognosy,
University of Milan, Italy (WHO Temporary Adviser)
Mr R. Haigh, Principal Administrator, Commission of the European
Communities, Brussels, Belgium (WHO Temporary Adviser)
Dr V. L. Kossila, Animal Production Officer, Feed Resources, Animal
Protection and Health Division, FAO, Rome, Italy
Dr G. D. Kouthon, Nutrition Officer, Food Policy and Nutrition
Division, FAO, Rome, Italy (Joint Secretary)
Dr M. Mercier, Manager of the International Programme on Chemical
Safety, Division of Environmental Health, WHO, Geneva,
Switzerland
Dr I. C. Munro, Director-General, Food Directorate, Health Protection
Branch, Department of National Health and Welfare, Ottawa, Canada
(WHO Temporary Adviser)
Dr N. Rao Maturu, Food Standards Officer, Joint FAO/WHO Food Standards
Programme, Food Policy and Nutrition Division, FAO, Rome, Italy
Dr S. I. Shibko, Chief, Contaminants and Natural Toxicants Evaluation
Branch, Division of Toxicology, Bureau of Foods, Food and Drug
Administration, Washington, D.C., United States of America
(WHO Temporary Adviser)
Dr P. Shubik, Resident Fellow, Green College, Oxford, England
(WHO Temporary Adviser)
Professor R. Truhaut, Director, Toxicological Research Centre, René
Descartes University, Paris, France (WHO Temporary Adviser)
Professor W. Velle, Department of Physiology, Veterinary College of
Norway, Oslo, Norway (FAO Temporary Adviser)
Dr G. Vettorazzi, Toxicologist, International Programme on Chemical
Safety, Division of Environmental Health, WHO, Geneva
(Joint Secretary)
Dr R. Walker, Department of Biochemistry, University of Surrey,
Guildford, England (WHO Temporary Adviser)
Dr A. Zaitsev, Head, Laboratory for the Hygienic Examination of Food
Additives, Institute of Nutrition, Academy of Medical Sciences,
Moscow, USSR (WHO Temporary Adviser)
ACCEPTABLE DAILY INTAKE (ADI) AND INFORMATION ON SPECIFICATIONS
ADI for man (mg/kg of
Specifications1 body weight) and other
toxicological decisions
Food colours
Allura Red R 0-7
Brilliant Black PN R 0-1
Brown HT (formerly
Chocolate Brown HT) R 0-2.52
carmines (formerly
cochineal, carmine
and carminic acid) NT 0-2.52
Fast Green FCF S 0-12.52
Ponceau 4R R 0-0.1252
Red 2G R 0-0.1
riboflavin-5'-phosphate N 0-0.53
Flavouring agents
ß-asarone O No ADI allocated
(+) carvone and (-)
carvone R 0-12
cinnamaldehyde R 0-0.72
cinnamyl anthranilate O Not to be used4
coumarin O No ADI allocated
estragole NT No ADI allocated
ethylmethyl ketone R No ADI allocated
ethyl 3-phenylglycidate R No ADI allocated
eugenyl methyl ether NT No ADI allocated
hydrocyanic acid O Not to be used5
ACCEPTABLE DAILY INTAKE (ADI) AND INFORMATION ON SPECIFICATIONS
(Con't)
ADI for man (mg/kg of
Specifications1 body weight) and other
toxicological decisions
Flavouring agents (Con't)
magnesium glutamate N 0-1206
maltol R 0-1
methyl ß-naphthyl
ketone RT No ADI allocated
octanal R 0-0.062
p-propylanisole NT No ADI allocated
safrole and isosafrole O No ADI allocated
thujone and isothujone
(alpha- and ß-thujone) O No ADI allocated
Sweetening agents
acesulfame potassium NT No ADI allocated
aspartame R 0-4016
isomaltitol NT 0-252
Thickening agents
carob (locust) bean gum S ADI not specified7
pectins R ADI not specified7,8
pectins (amidated) N ADI not specified7
tara gum TS 0-12.52
Extraction solvents
light petroleum R ADI not specified7
2-nitropropane withdrawn Not to be used9
propan-1-ol (n-propanol) RT No ADI allocated
ACCEPTABLE DAILY INTAKE (ADI) AND INFORMATION ON SPECIFICATIONS
(Con't)
ADI for man (mg/kg of
Specifications1 body weight) and other
toxicological decisions
Extraction solvents (Con't)
propan-2-ol (isopropanol) RT No ADI allocated
toluene R ADI not specified7,10
1,1,1-trichloroethane O No ADI allocated
Carrier solvents
diethyl tartrate NT No ADI allocated
1,2-propylene glycol
acetate O 0-2511
triethyl citrate S 0-102
triglycerides (synthetic) O No ADI allocated
Miscellaneous food additives
calcium ascorbate O ADI not specified7,10,12
polydextroses R13 0-7014
polyvidone (poly(vinyl
pyrrolidone; PVP) S 0-1
sodium sesquicarbonate N ADI not specified7,10,15
Specifications only
Extraction solvents Specifications1
butane O
butan-1-ol R
butan-2-ol O
cyclohexane R
Specifications only
Extraction solvents Specifications1
1,1-dichloroethane O
diethylene glycol monoethyl ether R
diisopropyl ether O
ethylmethyl ketone R
furfural S
isopropyl acetate NT
tetrachloroethylene O
1,1,2-trichlorotrifluoroethane NT
Notes
1. N, new specifications prepared; O, specifications not prepared;
R, existing specifications revised; S, specifications exist,
revision not considered; T, the existing, new or revised
specifications are tentative and comments are invited.
2. Temporary acceptance.
3. Group ADI for riboflavin and riboflavin-5'-phosphate expressed as
riboflavin.
4. On the available evidence, this substance should not be used as a
food additive.
5. Hydrogen cyanide and its salts should not be used as such as food
additives.
6. Group ADI for other glutamate, calculated and expressed as
glutamic acid.
7. The statement "ADI not specified" means that, on the basis of the
available data (chemical, biochemical, toxicological, and other),
the total daily intake of the substance, arising from its use at
the levels necessary to achieve the desired effect and from its
acceptable background in food, does not, in the opinion of the
Committee, represent a hazard to health. For this reason, and for
the reasons stated in the individual evaluations, the
establishment of an acceptable daily intake (ADI) is not deemed
necessary.
8. Group ADI for pectins and amidated pectins, singly or in
combination.
9. This solvent should not be used in food processing.
10. Residues of toluene occurring in foods when this solvent is used
in accordance with good manufacturing practice would not pose any
toxicological problems.
11. Group ADI for propylene glycol esters of fatty acids calculated
and expressed as propylene glycol.
12. Group ADI. The Committee concluded that the ADI for ascorbic acid
and its potassium and sodium salts should be changed from
0-15 mg/kg of body weight to "not specified", and that the
calcium salt should be included in this ADI.
13. The specifications were revised to include a limit for
5-hydroxymethylfurfural of 0.05%.
14. The ADI is for polydextrose A and polydextrose N, singly or in
combination.
15. Group ADI for other carbonates and bicarbonates established in
the ninth report of the Committee.
16. An ADI for diketopiperazine - an impurity found in aspartame was
established at 0-7.5 mg/kg bw.
CONTENTS
THE MONOGRAPHS
Acesulfame Potassium
Aspartame*
beta-Asarone
Brilliant BLACK PN
Calcium ascorbate
Carob (locust) bean gum
Cinnamyl anthranilate
Carmines (formerly Cochineal, Carmine and Carminic acid)
Coumarin
Eugenyl methyl ether
Fast Green FCF
Isomaltitol
Light petroleum
Maltol
2-Nitropropane
Pectins and Amidated Pectins
Polydextroses
Propan-1-ol (n-Propanol)
Red 2G
Riboflavin-5'-phosphate
Safrole
Tara gum
Toluene
Thujone
1,1,1-Trichloroethane
ANNEX
* Addendum.
See Also:
Toxicological Abbreviations